India’s National Pharmaceutical Pricing Authority (NPPA) has issued new regulations on drugs not currently under the mandatory price control list. These drugs are referred to as “non-scheduled formulations” and are currently sold freely. Companies will be short-listed for price control if they... Read More
On February 15, 2007 the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan recently drafted a proposal to introduce changes to the current available consultative sessions. The PMDA offers various consultative sessions to help applicants navigate the regulatory process. Some of these... Read More
Currently, India has only just begun to address medical devices as a separate regulatory category. Generally, regulation of medical devices is only conducted by officially classifying certain devices as “drugs” and subject to drug laws. Since March 1, 2006 there have been... Read More
The Government of India’s Union Cabinet has approved the establishment of the Central Drugs Authority of India. This Authority would be an autonomous organization under the Ministry of Health & Family Welfare. Currently, the Central Drug Standards Control Organization works with the... Read More
The US and Japan are currently working to expedite medical device approvals through the “Harmonization by Doing” (HBD) initiative. The HBD program was launched in December 2003, with its first meeting held in December 2005. A second meeting will take place in... Read More
India’s Department of Science and Technology (DST) has recently prepared a draft legislation on a regulatory framework for medical devices. Currently, some medical devices are classified as drugs and are regulated by the Central Drugs Standard Control Organization. However, since many of... Read More
The Asian Harmonization Working Party (AHWP) has recently drafted a “Common Submission Dossier Template” (CSDT). If adopted, this would allow medical device companies to use one common form when submitting to any of the 13 countries in the AHWP. By adopting this... Read More
India’s Central Drugs Standard Control Organization (CDSCO) has recently passed new regulations on global clinical trials. The regulations are based on a meeting held in October 2006, which brought together clinical trial specialists, manufacturers’ associations, and contract research organizations. In the process... Read More
On October 10, 2006 the Ministry of Health, Labor and Welfare of Japan, the Pharmaceuticals and Medical Devices Agency of Japan (PMDA), and the US FDA held a conference on drug review and safety to assess current pharmaceutical regulations and trends in... Read More
With soaring clinical trial costs and long development periods, many companies have turned to India to conduct cheaper, faster clinical trials. The potential cost savings of 40 to 60 percent together with a large, ethnically diverse population and an increasing pool of... Read More